Outsource FDA approval and technical validation documentation to our expert team. Our seven-step design documentation process produces all required documents that must be on file with your machine’s end users. Documentation is included for all PharmaMed standard and custom automation products.
Our documentation packages include OEM design engagement and our seven-step design documentation process.
- User Requirement Specification (URS)
- Electrical schematics, Network design, I/O List
- 3D Models, 2D Floor Layouts, Renderings
- Sourced Bill of Materials (BOM)
- OEM technical review of draft validation documents
Seven-Step Design Documentation Process.
- STEP 1 – Functional Design Specification (FDS)
- STEP 2 – Hardware Design Specification (HDS)
- STEP 3 – Software Design Specification (SDS)
- STEP 4 – Risk Assessment (RA)
- STEP 5 – SISTEMA Report (SR)
- STEP 6 – Factory Acceptance Test Protocol (FAT)
- STEP 7 – Site Acceptance Test Protocol (SAT)